Element Science, a pioneering health technology company specializing in cardiovascular care for high-risk patients, has recently achieved the European Union's CE mark certification and Great Britain's UK Conformity Assessed (UKCA) marking for its innovative Patch Wearable Cardioverter Defibrillator (P-WCD).
The Jewel P-WCD represents a significant advancement over conventional garment-based WCDs, which have struggled with issues of patient comfort and adherence despite their effectiveness in treating sudden cardiac arrest (SCA), a leading cause of mortality in both the United States and Europe. Notably, the effectiveness of the Jewel defibrillator was validated in the Jewel EP Lab Study conducted in Prague, Czech Republic, where 16 patients experiencing ventricular arrhythmias were successfully restored to a normal heart rhythm after receiving a single therapeutic shock.
The development of the Jewel P-WCD signifies a departure from traditional medical device design, incorporating user experience principles and advanced machine learning algorithms commonly found in consumer wearables but rarely seen in medical device innovation. The attainment of the CE mark under the stringent European Union Medical Device Regulation (EU MDR) and the UKCA mark underscores the rigorous development process, comprehensive testing, and compelling clinical outcomes of the Jewel P-WCD.
This innovative approach promises to deliver an exceptional patient experience and offers advantages that could expand the accessibility of WCDs to a wider patient population. Engineered with a focus on improving adherence, the Jewel P-WCD, supported by clinical evidence demonstrating its ability to deliver life-saving therapy when needed, has the potential to significantly improve survival rates in out-of-hospital cardiac arrest (OHCA), addressing a critical public health challenge.
Source: https://www.businesswire.com/news/home/20240125437671/en/Element-Science-Receives-CE-Mark-UKCA-Mark-for-the-Jewel%C2%AE-Patch-Wearable-Cardioverter-Defibrillator
